Treatment of Early Nasal Polyposis With Topical Triamcinolone

NCT01222871 | Terminated Phase 1 Results

• 1 other identifier: 00540
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.

Conditions

Nasal Polyps

Keywords

Treatment

Outcome Measures

Primary Outcomes (1)

• Nasal Endoscopic Exam Findings .

  nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.

  2 weeks, 6 weeks, 12 weeks were not collected from any participant.

Study Arms (2)

Triamcinolone

EXPERIMENTAL

Triamcinolone soaked nasopore dressing

Drug: Triamcinolone

Control Group

PLACEBO COMPARATOR

Saline soaked sponge

Drug: Saline soaked sponge

Interventions

Triamcinolone DRUG

Triamcinolone soaked nasopore dressing

Also known as: Kenalog (40)

Triamcinolone

Saline soaked sponge DRUG

saline soaked sponge

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients with early nasal polyposis

You may not qualify if:

• Age \< 18 years
• Patients with active sinus infections
• Patients on long term steroids
• Allergy or sensitivity to steroids
• Patients with Antrochoanal polyps
• Patients who received topical steroids by bio-resorbable sponge or oral steroids

Sponsors & Collaborators

• Steward St. Elizabeth's Medical Center of Boston, Inc.: lead

Study Sites (1)

St. Elizabeth's Medical Center, 736 Cambridge St

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Peter catalano
• Organization: SEMC

peter.catalano@steward.org

1-617-789-5004

Study Officials

• Peter Catalano, MD

  Steward St. Elizabeth's Medical Center of Boston, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Otolaryngology

Model Details: Patients will be randomized into 2 study groups, experimental and control.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 28, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)